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Effervescent Cold Relief (Tower Laboratories Ltd)

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TABLET, EFFERVESCENT 2 TABLET, EFFERVESCENT in 1 POUCH (50201-0246-1) Label Information

Complete Effervescent Cold Relief Information

  • ACTIVE INGREDIENT

    Active Ingredients (in each effervescent tablet)                              Purpose

    Aspirin 325 mg NSAID*..........................................                 Pain reliever/fever reducer
    Chlorpheniramine maleate 2 mg ...............................                 Antihistamine
    Phenylephrine Bitartrate 7.8 mg ...............................                 Nasal decongestant

    *Nonsteroidal anti-inflammatory drug


  • WARNINGS

    Warnings

    Reye's syndrome: Children and teenagers should not use this drug for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

    Allergy alert: Aspirin may cause a server allergic reaction which may include: - hives - facial swelling - asthma (wheezing) - shock

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you - are age 60 or older - have had stomach ulcers or bleeding problems - take a blood thinning (anticoagulant) or steroid drug - take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) - have 3 or more alcoholic drinks every day while using this product - take more or for a longer time than directed.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


  • ASK DOCTOR

    Ask a doctor before use if - stomach bleeding warning applies to you - you have a history of stomach problems, such as heartburn - you have high blood pressure, heart disease, liver cirrhosis, or kidney disease - glaucome - diabetes - thyroid disease - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema or chronic bronchitis - you are taking a diuretic - been placed on a sodium-restricted diet.


  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are:

    - presently taking a prescription drug.
    - taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis.


  • DO NOT USE

    Do not use - if you have ever had an allergic reaction to any other pain reliever/fever reducer - if you are allergic to aspirin - if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.  If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.  It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


  • PURPOSE

    Fast Relief of: Nasal Congetion, Runny Nose, Sneezing, Headache, Sinus Pain and Pressure


  • INDICATIONS & USAGE

    Uses:temporarily relieves these symptoms of the common cold:

    - fever - sneezing - nasal congestion - sore throat - headache - minor aches and pains - runny nose - sinus congestion and pressure


  • STOP USE

    Stop use and ask a doctor if - you experience any of the following signs of stomach bleeding - feel faint - vomit blood - have bloody stools - have stomach pain that does not get better - an allergic reaction occurs, seek medical help right away. - pain or nasal congestion gets worse or lasts more than 7 days. - fever gets worse or lasts more than 3 days. - new symptoms occur - redness or swelling is present - ringing in the ears or loss of hearing occurs - nervousness, dizziness or sleeplessness occurs.


  • WHEN USING

    When using this product:

    - do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by a doctor.
    - do not use more than directed
    - you may get drowsy
    - avoid alcoholic drinks
    - excitability may occur, especially in children
    - alcohol, sedatives and tranquilizers may increase drowsiness
    - be careful when driving a motor vehicle or operating machinery


  • ADVERSE REACTIONS

     Adverse Event Reporting: Serious side effects associated with the use of this product can be reported to the following address or by calling the following telephone number.


  • DOSAGE & ADMINISTRATION


    Directions

    - do not use more than directed (see overdose warning)
    - adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours
    - do not take more than 8 tablets in 24 hours

    - children under 12 years: ask a doctor


  • INACTIVE INGREDIENT


    Inactive ingredients:

    acesulfame potassium, aspartame, citric acid, docusate sodium, mannitol, povidone, sodium benzoate, sodium bicarbonate


  • PRINCIPAL DISPLAY PANEL

     image of carton


  • INGREDIENTS AND APPEARANCE
    EFFERVESCENT COLD RELIEF  
    aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50201-0246
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 25mm
    Flavor LEMON (N&A Lemon Lime Flavor FAKP193) Imprint Code CF
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50201-0246-1 2 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/01/2010
    Labeler - Tower Laboratories Ltd (001587203)
    Registrant - Tower Laboratories Ltd (869024500)
    Establishment
    Name Address ID/FEI Business Operations
    Tower Laboratories Ltd 869024500 manufacture(50201-0246)